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Guide to Combat Crime Related to Falsified Medical Products

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COMBATING

FALSIFIED MEDICAL PRODUCT-RELATED

CR ME

A GUIDE TO GOOD
LEGISL ATIVE PRACTICES

UNITED NATIONS OFFICE ON DRUGS AND CRIME

COMBATING

FALSIFIED MEDICAL
PRODUCT-RELATED CRIME:

A GUIDE TO GOOD LEGISLATIVE
PRACTICES

UNITED NATIONS

Vienna, 2019

i

Acknowledgements

is Guide was prepared by the Organized Crime Branch, Division for Treaty Affairs, United Nations Office on Drugs and Crime, and was funded by France.

is Guide benefited from the invaluable contributions of numerous experts in falsified medical products from all continents of the world, acting in their individual capacity.

e United Nations Office on Drugs and Crime also wishes to thank the Council of Europe, the Economic Community of West African States, the European Union, the International Council of Nurses, the International Criminal Police Organization (INTERPOL), the New Partnership for Africa’s Development, the World Customs Organization and the World Health Organization for providing their expertise.

Core team

Hugo Bonar, Antonio De Vivo, Marion Ehalt, Karen Kramer, Riikka Puttonen and Christian Tournié

Legal editing

Colin Craig © United Nations, May 2019. e designations employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the United Nations concerning the legal status of any country, territory, city or area, or of its authorities, or concerning the delimitation of its frontiers or boundaries. is publication may be reproduced in whole or in part and in any form for educational or nonprofit purposes without special permission from the copyright holder, provided acknowledgement of the source is made. UNODC would appreciate receiving a copy of any publication that uses this publication as a source.

Publishing production: English, Publishing and Library Section, United Nations Office at Vienna. Photo credits cover: © iStock.com/FotografiaBasica

ii

CONTENTS

Introduction ................................................................................................................................1

Statement of the problem............................................................................................................. 1 Definition of falsified medical products..................................................................................... 2 Legal framework ........................................................................................................................... 2 How to use this Guide .................................................................................................................. 3

Chapter I. General provisions..................................................................................................5

Objectives and scope of application of this Guide .................................................................... 5 Jurisdiction .................................................................................................................................... 6 Glossary of terms .......................................................................................................................... 7 Important definitions ................................................................................................................... 8

Chapter II. Prevention of falsified medical products............................................................13

Regulating the supply chain....................................................................................................... 13 Research and data collection, exchange and analysis ............................................................. 16

Chapter III. Offences..............................................................................................................19

Elements of criminal offences.................................................................................................... 19 Offences covered by this Guide................................................................................................. 20
A. General offences.......................................................................................................................... 21
Manufacture of a falsified medical product ............................................................................. 21 Trafficking in falsified medical products.................................................................................. 24 Possession of falsified medical products intended (or likely) to be used in manufacturing or placed in the distribution system............................................................... 25

Offences related to trafficking in falsified medical products by electronic and distance selling ............................................................................................................................ 26

Failure to report .......................................................................................................................... 27
B. Offences related to the falsification of documents, equipment, implements and materials ............................................................................................................................... 28

C. Related offences........................................................................................................................... 29
Conspiracy or criminal association .......................................................................................... 29

iii

Secondary liability ...................................................................................................................... 31 Obstruction of justice................................................................................................................. 32 Money-laundering ...................................................................................................................... 34
D. Penalties, sentencing and other orders..................................................................................... 35

Imprisonment.............................................................................................................................36 Non-custodial penalties and other orders...............................................................................37 Additional penalties...................................................................................................................37 Aggravating and mitigating circumstances.............................................................................38

Chapter IV. Liability of legal persons ....................................................................................41 Chapter V. Investigations .......................................................................................................47

Special investigative techniques ................................................................................................ 48 Controlled delivery..................................................................................................................... 49 Assumed identities and infiltration .......................................................................................... 49 Electronic surveillance ............................................................................................................... 50 Seizure and confiscation............................................................................................................. 50 Collection and analysis of samples and certificates of result of tests, examinations or analyses.................................................................................................................................... 51

Disposal........................................................................................................................................ 52

Chapter VI. Prosecution of offences......................................................................................53

Detention pending trial.............................................................................................................. 53 Prosecutorial discretion ............................................................................................................. 53 Alternatives to trial..................................................................................................................... 54 Statute of limitations................................................................................................................... 54

Chapter VII. National and international cooperation..........................................................57

National cooperation.................................................................................................................. 57 International cooperation.......................................................................................................... 59 Mutual legal assistance............................................................................................................... 60 Extradition................................................................................................................................... 60 Law enforcement cooperation................................................................................................... 61 Joint investigations...................................................................................................................... 62

Chapter VIII. Protection of and assistance to witnesses and victims...................................65

Safety of victims and witnesses.................................................................................................. 65 Provision of care to victims ....................................................................................................... 66 Compensation and restitution for victims............................................................................... 66 Protective disclosure (whistle-blower protection) .................................................................. 67

iv

Introduction

is Guide was developed in response to Commission on Crime Prevention and Criminal Justice resolution 20/6, entitled “Countering fraudulent medicines, in particular their trafficking”. As the Commission has noted, organized criminal groups are involved in all aspects of falsified medical product-related crime. In its resolution 20/6, the Commission underscored the potential utility of the United Nations Convention against Transnational Organized Crime in reinforcing international cooperation to fight such crime and requested the United Nations Office on Drugs and Crime (UNODC), in cooperation with other United Nations bodies and international organizations, to assist Member States in building capacity to disrupt and dismantle the organized criminal networks engaged in all stages of the illicit supply chain, in particular distribution and trafficking.

As explained in detail further on, in this Guide, the term “falsified medical products” is used, along with the definition of that term as adopted by the World Health Assembly in 2017.1 Nothing in this Guide is to be interpreted as applying to intellectual property rights or as making a distinction between originator medicines and generic medicines.

Statement of the problem

e growing phenomenon of the falsification of medical products threatens the right to life, as enshrined in different international human rights instruments. In its resolution 20/6, the Commission on Crime Prevention and Criminal Justice urged Member States to prevent trafficking in fraudulent medicines by introducing legislation, as appropriate, covering, in particular, all offences related to fraudulent medicines, such as money-laundering, corruption and smuggling, a well as the confiscation and disposal of criminal assets, extradition and mutual legal assistance, to ensure that no stage in the supply chain of fraudulent medicines was overlooked.

According to the limited number of studies on the magnitude of the problem,2 organized criminal groups engage in falsified medical product-related crime using the same routes and techniques employed in the trafficking in other illicit commodities. In so doing, they exploit gaps and discrepancies in national legislation and criminal justice systems. In many countries, criminal groups use new technologies and platforms such as darknet sites to traffic in falsified medical products and avoid detection by law enforcement authorities.

1 World Health Organization (WHO), Report by the Director-General on the Member State mechanism on substandard/spurious/ falsely-labelled/falsified/counterfeit medical products, Report of the Director-General, document A70/23, annex, appendix 3.

2 WHO, A Study on the Public Health and Socioeconomic Impact of Substandard and Falsified Medical Products (Geneva, 2017); WHO, WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products (Geneva, 2017); and e Globalization of Crime: A Transnational Organized Crime reat Assessment (United Nations publication, Sales No. E.10.IV.6).

1

COMBATING FALSIFIED MEDICAL PRODUCT-RELATED CRIME: A GUIDE TO GOOD LEGISLATIVE PRACTICES

Despite the growing nature of the problem, legal systems around the world are facing numerous challenges in effectively combating these crimes. Such challenges include weak or inconsistent legal frameworks and ineffective criminal laws that oſten fail to criminalize attempt, participation by accessories and the possession and sale of illegally obtained medical products. Online and distance selling of medical products are also growing concerns but are oſten still inadequately addressed. Many medical product sector-specific laws are inadequate and not harmonized with other laws and international standards. Some laws lack definitions, provide for insufficient penalties and fail to designate offences as predicate offences in anti-money-laundering legislation.

e World Health Organization (WHO) recognizes that falsified medical products are most likely to be found where access to affordable, quality, safe and effective medical products is constrained, standards of governance are low or the tools and technical capacity to ensure good practices in manufacturing, quality control and distribution are limited. While the deleterious impacts of falsified medical products are difficult to quantify, there is no doubt that such products have a multidimensional impact that includes health, economic and socioeconomic consequences. ey endanger health, prolong illness, kill, promote antimicrobial resistance and the spread of drug-resistant infections, undermine confidence in health professionals and health systems, create distrust about the effectiveness of medical products, waste resources, cut into the limited budgets of families and health systems and provide income for criminal networks.

Definition of falsified medical products

In its resolution 20/6, the Commission on Crime Prevention and Criminal Justice uses the term “fraudulent medicines”. In the past, UNODC has used the terms “fraudulent medicines” and “falsified medicines” interchangeably. Both terms were used with the clear understanding that intellectual property rights were not included.

e term “falsified medical products” is used in this Guide, following the adoption of the term by the World Health Assembly in 2017.3 As noted by WHO, the term “falsified” appears to adequately include all the various types of deliberate misrepresentation of a medical product in such a way as to enable the specific exclusion of intellectual property rights.4

To avoid legislative gaps and minimize risks to public health, a broad definition of medical products is used in this Guide. For the purposes of this Guide, the term “medical products” means medicines, excipients and active substances, as well as medical devices, their parts and materials, and accessories used in conjunction with medical devices. is definition takes into account the very close relationship between medicines and medical devices, as well as the fact that criminals do not distinguish between the two types of medical products in their criminal activities and, ultimately, that both falsified medicines and falsified medical devices cause harm to members of the public.

Legal framework

As recognized by the Commission on Crime Prevention and Criminal Justice with the adoption of its resolution 20/6, there is a need for more initiatives concerning falsified medical product-related crime. It is imperative that initiatives are undertaken in cooperation with each other to combat falsified medical product-related crime and, in particular, the organized criminal activities that facilitate falsified medical products reaching vulnerable consumers.

3 As specified in WHO document A70/23, annex, appendix 3, para. 7 (c), falsified medical products are medical products that deliberately/fraudulently misrepresent their identity, composition or source. Any consideration related to intellectual property rights does not fall within this definition. Such deliberate/fraudulent misrepresentation refers to any substitution, adulteration, reproduction of an authorized medical product or the manufacture of a medical product that is not an authorized product.
4 e term “counterfeit” is now usually defined and associated with the protection of intellectual property rights. For reference purposes, the definitions of “trademark counterfeit goods” and “pirated copyright goods” are included as defined under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) (WHO document A70/23, annex, appendix 3, para. 8).

2

INTRODUCTION

In this Guide, the good practices and existing work of Member States and of regional and international organizations are used and built upon. e following instruments, in particular, were used in the preparation of this Guide:

•••
United Nations Convention against Transnational Organized Crime United Nations Convention against Corruption Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes Involving reats to Public Health (MEDICRIME Convention)

  • •
  • “Legal framework on the counterfeiting of and illicit trade in medical products for ECOWAS

member States” (available in French only at the time of publication of this Guide)
••

African Union Model Law on Medical Products Regulation

Directive 2011/62/EU of the European Parliament and of the Council of the European Union of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products

How to use this Guide

is Guide is intended to support States in enacting or strengthening domestic legislation to combat falsified medical product-related crime and, in so doing, contributing to the protection of public health. States may use this Guide as a practical tool as they draſt, amend or review relevant national legislation within their constitutional and legislative framework. It is not a model law and does not provide a “one-size-fits-all” model ready to be introduced into a State’s legal system. Rather, it is recognized that legislation must be tailored to each State’s legal tradition and social, economic, cultural and geographical conditions. States should adapt the sample provisions and guidance provided in this Guide to implement treaty obligations and fit local conditions, constitutional principles, legal culture and structures and existing enforcement arrangements. It is recommended in this Guide that States consult with relevant stakeholders as they engage in the process of draſting, amending or reviewing legislation.

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